This purpose of this study was to evaluate effectiveness of a risk-based dental caries prevention program conducted by dental personnel at an urban pediatric primary care clinic serving largely low-income residents of Baltimore, Maryland, and to appraise this program as a model for similar urban pediatric settings.

Further study details as provided by University of Maryland Baltimore Dental School:

Primary Outcome Measures:

dmfs scores [ Time Frame: 12 months ]

Secondary Outcome Measures:

caries-preventive behaviors by care-givers [ Time Frame: 12 months ]

Enrollment:

219

Study Start Date:

June 2004

Study Completion Date:

August 2006

Detailed Description:

A demonstration caries prevention trial lasting 26 months was conducted with a total of 219 children aged 6 to 27 months of age. The “prevention” group consisting of children 6-15 months of age at their initial visit were compared at the end of the trial with a “comparison” group at their initial visit. The comparison group was 12 months older than the enrollment age of the prevention group (18-27 months) and had not received previous routine professional dental care. Interventions were dental examination and periodic recalls, caries-risk assessments, monitoring of oral mutans streptococci (MS) levels, application of 5.0% sodium fluoride varnish to teeth, dental health counseling to care-givers, referral for dental treatment if indicated and periodic recalls.

Outcome measures were: 1) number of decayed, missing, filled primary tooth surfaces, 2) number of pre-carious lesions, 3) counts of oral MS and 3) care-giver responses to a questionnaire about the child’s diet and home care.

Prevention group children at the last recall experienced fewer mean carious dental surfaces (0.1 vs. 1.29, p<0.014) and over 8-fold less MS (p<0.013) than comparison group subjects at the initial visit. The number of precarious lesions, however, were not significantly different. In the absence of carious or precarious lesions, oral levels of MS was a reliable indicator of caries risk status, particularly for low risk subjects (sensitivity, 0.64; specificity, 0.98). Caregiver reports of dietary practices and presence or absence of visible dental plaque also served as caries-risk determinants.

Eligibility

Ages Eligible for Study:

6 Months to 27 Months (Child)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

children in good health who were dentate and 6-27 months

a signed informed consent

Exclusion Criteria:

antibiotic usage within the previous 14 days

oral topical fluoride administration within the previous 7 days

previous routine professional dental care

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497029

Locations

United States, Maryland

University of Maryland Medical Center: Pediatric Ambulatory Center

Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

University of Maryland Baltimore Dental School

Investigators

Principal Investigator:

Glenn E Minah, DDS, PhD

Department of Biomedical Sciences, University of Maryland Dental School